Evaluation of the Effect of Acetazolamide, Mannitol and N-acetylcysteine on Cisplatin-Induced Nephrotoxicity
NCT ID: NCT02760901
Last Updated: 2017-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2013-11-30
2016-10-31
Brief Summary
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Aim of the study was to evaluate the effect of acetazolamide or NAC against cisplatin nephrotoxicity in humans compared to mannitol and to each other.
Patients and methods. A total 52 patients receiving standard hydration measures for cisplatin were randomized to three groups: 20 patients receiving mannitol, 15 patients receiving acetazolamide and 17 patients receiving NAC. Patients' kidney function was monitored using serum creatinine, creatinine clearance and blood urea nitrogen; kidney injury was assessed using RIFLE criteria. Patients' liver function tests and hematological parameters were also monitored.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Mannitol group
patients received mannitol 20 % 100 ml half an hour before cisplatin and saline hydration.
Mannitol
patients received mannitol 20 % 100 ml half an hour before cisplatin and saline hydration.
saline
saline hydration 2500 ml before cisplatin therapy
Cisplatin
patients with tumours already prescribed cisplatin
ACTZ group
patients received acetazolamide 250 mg half an hour before cisplatin with saline hydration.
Acetazolamide
patients received acetazolamide 250 mg half an hour before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity
saline
saline hydration 2500 ml before cisplatin therapy
Cisplatin
patients with tumours already prescribed cisplatin
NAC group
patients received acetylcysteine NAC (600 mg every 12 hours) for 4 doses beginning 24 hours before cisplatin with saline hydration.
Acetylcysteine
patients received NAC (600 mg every 12 hours) for 4 doses beginning 24 hours before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity
saline
saline hydration 2500 ml before cisplatin therapy
Cisplatin
patients with tumours already prescribed cisplatin
Interventions
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Acetazolamide
patients received acetazolamide 250 mg half an hour before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity
Acetylcysteine
patients received NAC (600 mg every 12 hours) for 4 doses beginning 24 hours before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity
Mannitol
patients received mannitol 20 % 100 ml half an hour before cisplatin and saline hydration.
saline
saline hydration 2500 ml before cisplatin therapy
Cisplatin
patients with tumours already prescribed cisplatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Adult patients from 18 to 65 years.
Exclusion Criteria
2. Severe hepatic impairment (Child Pugh score C).
3. Hypersensitivity to sulfonamides.
4. Patients with chronic non-congestive angle closure glaucoma.
5. Hypersensitivity to sulphur compounds, N-acetylcysteine or any component of the formulation.
18 Years
65 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Noha Kamal Morsy Ibraheem
clinical pharmacist
Other Identifiers
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master
Identifier Type: -
Identifier Source: org_study_id
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